Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Insulin (IN-105) in Type 1 Diabetes Patients

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

It had two arms (groups): IN105 (experimental) and Insulin Lispro Injection (active comparator).

Prandial Oral Insulin.

The registry classes the interventions as drug.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and female patients between the ages of 18-45 years inclusive. Established diagnosis of T1DM for at least 1-year. Body mass index of 18.5-29.9 kg/m2 inclusive. Stable weight with no more than 5 kg gain or loss within 3 months of screening. On stable insulin or an insulin analogue regimen for at least 3 months.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: any hypersensitivity or allergy; positive urine ketones test at screening visit; ECG abnormality.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Everyone knew when Insulin Lispro was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-08-21 with completion listed for 2011-03-12.

It ran at 5 sites in India (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: AUC (Insulin and Blood Glucose) (time frame: 0-130 min).

It also tracked 2 secondary outcomes, for example AUC (Insulin and Blood Glucose) and Frequency of Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Insulin Lispro in 20 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Lispro compound page, all human trials.